Lazcluze (lazertinib) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

Citation

Janssen Biotech, Inc. Lazcluze (lazertinib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/219008s000lbledt.pdf. Revised August 2024. Accessed October 30, 2024.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
LAZCLUZE is a kinase inhibitor indicated in combination with amivantamab for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, as detected by an FDA-approved test.	2

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organizations	Biomarkers	Cancer types	Therapies
FDA (1)	EGFR Exon 19 (Deletion)	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib
FDA (1)	EGFR p.L858R	Non-Small Cell Lung Cancer	Amivantamab, Lazertinib